Trial Outcomes & Findings for King Vision® and GlideScope® in Difficult Airways (NCT NCT03685968)
NCT ID: NCT03685968
Last Updated: 2019-01-08
Results Overview
The overall intubation success rates for all 3 video laryngoscopes - GSAVL, KVChVL and KVNChVL
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
225 participants
Primary outcome timeframe
During laryngoscopy and endotracheal tube placement
Results posted on
2019-01-08
Participant Flow
Patients were enrolled from the adult surgical operating rooms of 2 academic hospitals, Lyndon Baines Johnson General Hospital and Memorial Hermann Hospital - Texas Medical Center, in Houston, TX from August 2013 to December 2015.
Participant milestones
| Measure |
Glidescope AVL
Group A: Patients were randomized into one of the three groups through a computer-generated randomization schedule. Patients in group A (N= 75) were intubated utilizing the GlideScope® AVL.
|
King Vision Channeled VL
Group B: Patients were randomized into one of the three groups through a computer-generated randomization schedule. Patients in group B (N= 75) were intubated utilizing the King Vision Channeled VL.
|
King Vision Non-Channeled (Standard) VL
Group C: Patients were randomized into one of the three groups through a computer-generated randomization schedule. Patients in group C (N=75) were intubated utilizing the King Vision Video Laryngoscope with Standard (Non-Channeled) Blade.
|
|---|---|---|---|
|
Overall Study
STARTED
|
75
|
75
|
75
|
|
Overall Study
COMPLETED
|
75
|
75
|
75
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
King Vision® and GlideScope® in Difficult Airways
Baseline characteristics by cohort
| Measure |
Glidescope AVL
n=75 Participants
Group A: Patients were randomized into one of the three groups through a computer-generated randomization schedule. Patients in group A (N= 75) were intubated utilizing the GlideScope® AVL.
|
King Vision Channeled VL
n=75 Participants
Group B: Patients were randomized into one of the three groups through a computer-generated randomization schedule. Patients in group B (N= 75) were intubated utilizing the King Vision Channeled VL.
|
King Vision Non-Channeled (Standard) VL
n=75 Participants
Group C: Patients were randomized into one of the three groups through a computer-generated randomization schedule. Patients in group C (N=75) were intubated utilizing the King Vision Video Laryngoscope with Standard (Non-Channeled) Blade.
|
Total
n=225 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
68 Participants
n=5 Participants
|
63 Participants
n=7 Participants
|
65 Participants
n=5 Participants
|
196 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
7 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
29 Participants
n=4 Participants
|
|
Age, Continuous
|
48.1 years
STANDARD_DEVIATION 11.8 • n=5 Participants
|
48.0 years
STANDARD_DEVIATION 15.2 • n=7 Participants
|
50.0 years
STANDARD_DEVIATION 14.2 • n=5 Participants
|
48.7 years
STANDARD_DEVIATION 13.7 • n=4 Participants
|
|
Sex: Female, Male
Female
|
39 Participants
n=5 Participants
|
41 Participants
n=7 Participants
|
40 Participants
n=5 Participants
|
120 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
36 Participants
n=5 Participants
|
34 Participants
n=7 Participants
|
35 Participants
n=5 Participants
|
105 Participants
n=4 Participants
|
|
Height (in)
|
66.7 inches
STANDARD_DEVIATION 4.2 • n=5 Participants
|
66.4 inches
STANDARD_DEVIATION 4.3 • n=7 Participants
|
66.4 inches
STANDARD_DEVIATION 4.2 • n=5 Participants
|
66.5 inches
STANDARD_DEVIATION 4.2 • n=4 Participants
|
|
Weight (kg)
|
117.5 kilograms
STANDARD_DEVIATION 20.3 • n=5 Participants
|
116.2 kilograms
STANDARD_DEVIATION 25.5 • n=7 Participants
|
116.8 kilograms
STANDARD_DEVIATION 21.5 • n=5 Participants
|
116.8 kilograms
STANDARD_DEVIATION 22.4 • n=4 Participants
|
|
BMI (kg/m2)
|
41.2 kilogram per meter square
STANDARD_DEVIATION 8.1 • n=5 Participants
|
41.4 kilogram per meter square
STANDARD_DEVIATION 9.9 • n=7 Participants
|
41.1 kilogram per meter square
STANDARD_DEVIATION 8.5 • n=5 Participants
|
41.2 kilogram per meter square
STANDARD_DEVIATION 8.8 • n=4 Participants
|
|
Neck Circumference (cm)
|
47.1 centimeters
STANDARD_DEVIATION 4.3 • n=5 Participants
|
47.1 centimeters
STANDARD_DEVIATION 4.7 • n=7 Participants
|
47.9 centimeters
STANDARD_DEVIATION 4.3 • n=5 Participants
|
47.3 centimeters
STANDARD_DEVIATION 4.4 • n=4 Participants
|
|
Interincisor distance (cm)
|
4.1 centimeters
STANDARD_DEVIATION 1.0 • n=5 Participants
|
4.1 centimeters
STANDARD_DEVIATION 0.9 • n=7 Participants
|
4.1 centimeters
STANDARD_DEVIATION 1.0 • n=5 Participants
|
4.1 centimeters
STANDARD_DEVIATION 0.9 • n=4 Participants
|
|
Thyromental distance (cm)
|
6.8 centimeters
STANDARD_DEVIATION 1.7 • n=5 Participants
|
6.8 centimeters
STANDARD_DEVIATION 1.9 • n=7 Participants
|
7.1 centimeters
STANDARD_DEVIATION 1.7 • n=5 Participants
|
6.9 centimeters
STANDARD_DEVIATION 1.7 • n=4 Participants
|
|
Sternomental distance (cm)
|
13.4 centimeters
STANDARD_DEVIATION 2.3 • n=5 Participants
|
13.6 centimeters
STANDARD_DEVIATION 2.3 • n=7 Participants
|
13.7 centimeters
STANDARD_DEVIATION 2.1 • n=5 Participants
|
13.5 centimeters
STANDARD_DEVIATION 2.2 • n=4 Participants
|
PRIMARY outcome
Timeframe: During laryngoscopy and endotracheal tube placementThe overall intubation success rates for all 3 video laryngoscopes - GSAVL, KVChVL and KVNChVL
Outcome measures
| Measure |
Glidescope AVL
n=75 Participants
Group A: Patients were randomized into one of the three groups through a computer-generated randomization schedule. Patients in group A (N= 75) were intubated utilizing the GlideScope® AVL.
|
King Vision Channeled VL
n=75 Participants
Group B: Patients were randomized into one of the three groups through a computer-generated randomization schedule. Patients in group B (N= 75) were intubated utilizing the King Vision Channeled VL.
|
King Vision Non-Channeled (Standard) VL
n=75 Participants
Group C: Patients were randomized into one of the three groups through a computer-generated randomization schedule. Patients in group C (N=75) were intubated utilizing the King Vision Video Laryngoscope with Standard (Non-Channeled) Blade.
|
|---|---|---|---|
|
Overall Successful Tracheal Intubation for All 3 Video Laryngoscopes - GSAVL, KVChVL and KVNChVL
|
72 Participants
|
61 Participants
|
72 Participants
|
SECONDARY outcome
Timeframe: During laryngoscopy and endotracheal tube placementThe overall first-attempt success rates for all 3 video laryngoscopes - GSAVL, KVChVL and KVNChVL
Outcome measures
| Measure |
Glidescope AVL
n=75 Participants
Group A: Patients were randomized into one of the three groups through a computer-generated randomization schedule. Patients in group A (N= 75) were intubated utilizing the GlideScope® AVL.
|
King Vision Channeled VL
n=75 Participants
Group B: Patients were randomized into one of the three groups through a computer-generated randomization schedule. Patients in group B (N= 75) were intubated utilizing the King Vision Channeled VL.
|
King Vision Non-Channeled (Standard) VL
n=75 Participants
Group C: Patients were randomized into one of the three groups through a computer-generated randomization schedule. Patients in group C (N=75) were intubated utilizing the King Vision Video Laryngoscope with Standard (Non-Channeled) Blade.
|
|---|---|---|---|
|
First-attempt Successful Intubation for All 3 Video Laryngoscopes - GSAVL, KVChVL and KVNChVL
|
64 Participants
|
53 Participants
|
67 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: During laryngoscopy and endotracheal tube placementPopulation: Group A: 3 participants excluded due to protocol deviations. Group B: 8 participants excluded due to protocol deviations, 2 participant had failed intubation, 4 participants had device failure. Group C: 2 participants excluded due to protocol deviations, 1 participant had device failure.
Total time for placing the endotracheal tube (ETT) through the vocal cords
Outcome measures
| Measure |
Glidescope AVL
n=72 Participants
Group A: Patients were randomized into one of the three groups through a computer-generated randomization schedule. Patients in group A (N= 75) were intubated utilizing the GlideScope® AVL.
|
King Vision Channeled VL
n=61 Participants
Group B: Patients were randomized into one of the three groups through a computer-generated randomization schedule. Patients in group B (N= 75) were intubated utilizing the King Vision Channeled VL.
|
King Vision Non-Channeled (Standard) VL
n=72 Participants
Group C: Patients were randomized into one of the three groups through a computer-generated randomization schedule. Patients in group C (N=75) were intubated utilizing the King Vision Video Laryngoscope with Standard (Non-Channeled) Blade.
|
|---|---|---|---|
|
Final Intubation Time for All 3 Video Laryngoscopes - GSAVL, KVChVL and KVNChVL
|
46.1 seconds
Standard Deviation 27.4
|
44.9 seconds
Standard Deviation 21.5
|
47.0 seconds
Standard Deviation 24.3
|
Adverse Events
Glidescope AVL
Serious events: 0 serious events
Other events: 26 other events
Deaths: 0 deaths
King Vision Channeled VL
Serious events: 0 serious events
Other events: 23 other events
Deaths: 0 deaths
King Vision Non-Channeled (Standard) VL
Serious events: 0 serious events
Other events: 22 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Glidescope AVL
n=64 participants at risk；n=75 participants at risk
Video laryngoscopes: Patients were randomized into one of the three groups through a computer generated randomization schedule. Patients in group A (N= 75) will be intubated using the GlideScope® AVL, patients in group B (N= 75) will be intubated using the King Vision Channeled VL; patients in group C (N=75) will be intubated using the King Vision Video Laryngoscope with Standard (non-channeled) Blade. Patients will only be tested with one device. All patients will be intubated using a conventional ETT.
|
King Vision Channeled VL
n=65 participants at risk；n=75 participants at risk
Video laryngoscopes: Patients were randomized into one of the three groups through a computer generated randomization schedule. Patients in group A (N= 75) will be intubated using the GlideScope® AVL, patients in group B (N= 75) will be intubated using the King Vision Channeled VL; patients in group C (N=75) will be intubated using the King Vision Video Laryngoscope with Standard (non-channeled) Blade. Patients will only be tested with one device. All patients will be intubated using a conventional ETT.
|
King Vision Non-Channeled (Standard) VL
n=70 participants at risk；n=75 participants at risk
Video laryngoscopes: Patients were randomized into one of the three groups through a computer generated randomization schedule. Patients in group A (N= 75) will be intubated using the GlideScope® AVL, patients in group B (N= 75) will be intubated using the King Vision Channeled VL; patients in group C (N=75) will be intubated using the King Vision Video Laryngoscope with Standard (non-channeled) Blade. Patients will only be tested with one device. All patients will be intubated using a conventional ETT.
|
|---|---|---|---|
|
General disorders
Hoarseness
|
40.6%
26/64 • Postoperatively in the PACU
(Other Adverse Events) Group A: 3 participants excluded due to protocol deviations, 8 participants lost to follow up. Group B: 8 participants excluded due to protocol deviations, 2 participant lost to follow up. Group C: 2 participants excluded due to protocol deviations, 3 participant lost to follow up.
|
35.4%
23/65 • Postoperatively in the PACU
(Other Adverse Events) Group A: 3 participants excluded due to protocol deviations, 8 participants lost to follow up. Group B: 8 participants excluded due to protocol deviations, 2 participant lost to follow up. Group C: 2 participants excluded due to protocol deviations, 3 participant lost to follow up.
|
31.4%
22/70 • Postoperatively in the PACU
(Other Adverse Events) Group A: 3 participants excluded due to protocol deviations, 8 participants lost to follow up. Group B: 8 participants excluded due to protocol deviations, 2 participant lost to follow up. Group C: 2 participants excluded due to protocol deviations, 3 participant lost to follow up.
|
|
General disorders
Sore Mouth
|
14.1%
9/64 • Postoperatively in the PACU
(Other Adverse Events) Group A: 3 participants excluded due to protocol deviations, 8 participants lost to follow up. Group B: 8 participants excluded due to protocol deviations, 2 participant lost to follow up. Group C: 2 participants excluded due to protocol deviations, 3 participant lost to follow up.
|
7.7%
5/65 • Postoperatively in the PACU
(Other Adverse Events) Group A: 3 participants excluded due to protocol deviations, 8 participants lost to follow up. Group B: 8 participants excluded due to protocol deviations, 2 participant lost to follow up. Group C: 2 participants excluded due to protocol deviations, 3 participant lost to follow up.
|
10.0%
7/70 • Postoperatively in the PACU
(Other Adverse Events) Group A: 3 participants excluded due to protocol deviations, 8 participants lost to follow up. Group B: 8 participants excluded due to protocol deviations, 2 participant lost to follow up. Group C: 2 participants excluded due to protocol deviations, 3 participant lost to follow up.
|
|
General disorders
Sore neck
|
14.1%
9/64 • Postoperatively in the PACU
(Other Adverse Events) Group A: 3 participants excluded due to protocol deviations, 8 participants lost to follow up. Group B: 8 participants excluded due to protocol deviations, 2 participant lost to follow up. Group C: 2 participants excluded due to protocol deviations, 3 participant lost to follow up.
|
6.2%
4/65 • Postoperatively in the PACU
(Other Adverse Events) Group A: 3 participants excluded due to protocol deviations, 8 participants lost to follow up. Group B: 8 participants excluded due to protocol deviations, 2 participant lost to follow up. Group C: 2 participants excluded due to protocol deviations, 3 participant lost to follow up.
|
10.0%
7/70 • Postoperatively in the PACU
(Other Adverse Events) Group A: 3 participants excluded due to protocol deviations, 8 participants lost to follow up. Group B: 8 participants excluded due to protocol deviations, 2 participant lost to follow up. Group C: 2 participants excluded due to protocol deviations, 3 participant lost to follow up.
|
|
General disorders
Sore jaw
|
6.2%
4/64 • Postoperatively in the PACU
(Other Adverse Events) Group A: 3 participants excluded due to protocol deviations, 8 participants lost to follow up. Group B: 8 participants excluded due to protocol deviations, 2 participant lost to follow up. Group C: 2 participants excluded due to protocol deviations, 3 participant lost to follow up.
|
1.5%
1/65 • Postoperatively in the PACU
(Other Adverse Events) Group A: 3 participants excluded due to protocol deviations, 8 participants lost to follow up. Group B: 8 participants excluded due to protocol deviations, 2 participant lost to follow up. Group C: 2 participants excluded due to protocol deviations, 3 participant lost to follow up.
|
2.9%
2/70 • Postoperatively in the PACU
(Other Adverse Events) Group A: 3 participants excluded due to protocol deviations, 8 participants lost to follow up. Group B: 8 participants excluded due to protocol deviations, 2 participant lost to follow up. Group C: 2 participants excluded due to protocol deviations, 3 participant lost to follow up.
|
|
General disorders
Dysphonia
|
10.9%
7/64 • Postoperatively in the PACU
(Other Adverse Events) Group A: 3 participants excluded due to protocol deviations, 8 participants lost to follow up. Group B: 8 participants excluded due to protocol deviations, 2 participant lost to follow up. Group C: 2 participants excluded due to protocol deviations, 3 participant lost to follow up.
|
4.6%
3/65 • Postoperatively in the PACU
(Other Adverse Events) Group A: 3 participants excluded due to protocol deviations, 8 participants lost to follow up. Group B: 8 participants excluded due to protocol deviations, 2 participant lost to follow up. Group C: 2 participants excluded due to protocol deviations, 3 participant lost to follow up.
|
7.1%
5/70 • Postoperatively in the PACU
(Other Adverse Events) Group A: 3 participants excluded due to protocol deviations, 8 participants lost to follow up. Group B: 8 participants excluded due to protocol deviations, 2 participant lost to follow up. Group C: 2 participants excluded due to protocol deviations, 3 participant lost to follow up.
|
|
General disorders
Dysphagia
|
20.3%
13/64 • Postoperatively in the PACU
(Other Adverse Events) Group A: 3 participants excluded due to protocol deviations, 8 participants lost to follow up. Group B: 8 participants excluded due to protocol deviations, 2 participant lost to follow up. Group C: 2 participants excluded due to protocol deviations, 3 participant lost to follow up.
|
21.5%
14/65 • Postoperatively in the PACU
(Other Adverse Events) Group A: 3 participants excluded due to protocol deviations, 8 participants lost to follow up. Group B: 8 participants excluded due to protocol deviations, 2 participant lost to follow up. Group C: 2 participants excluded due to protocol deviations, 3 participant lost to follow up.
|
12.9%
9/70 • Postoperatively in the PACU
(Other Adverse Events) Group A: 3 participants excluded due to protocol deviations, 8 participants lost to follow up. Group B: 8 participants excluded due to protocol deviations, 2 participant lost to follow up. Group C: 2 participants excluded due to protocol deviations, 3 participant lost to follow up.
|
|
General disorders
Alteration of tongue
|
3.1%
2/64 • Postoperatively in the PACU
(Other Adverse Events) Group A: 3 participants excluded due to protocol deviations, 8 participants lost to follow up. Group B: 8 participants excluded due to protocol deviations, 2 participant lost to follow up. Group C: 2 participants excluded due to protocol deviations, 3 participant lost to follow up.
|
0.00%
0/65 • Postoperatively in the PACU
(Other Adverse Events) Group A: 3 participants excluded due to protocol deviations, 8 participants lost to follow up. Group B: 8 participants excluded due to protocol deviations, 2 participant lost to follow up. Group C: 2 participants excluded due to protocol deviations, 3 participant lost to follow up.
|
2.9%
2/70 • Postoperatively in the PACU
(Other Adverse Events) Group A: 3 participants excluded due to protocol deviations, 8 participants lost to follow up. Group B: 8 participants excluded due to protocol deviations, 2 participant lost to follow up. Group C: 2 participants excluded due to protocol deviations, 3 participant lost to follow up.
|
Additional Information
Elizabeth M. Gendel
The University of Texas Health Science Center at Houston (UTHealth)
Phone: +1 (713) 500-3587
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place